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Alternative Non-Testing methods
Assessed for REACH Substances
Introduction
to the Project
www.antares-life.eu
Alternative Non-Testing
methods Assessed for
REACH Substances
Contents
03 The LIFE+ Project ANTARES
04 REACH and Non-Testing Methods
06 ANTARES Web Portal Overview
07 The sections of the Web Portal
10 Project Beneficiaries
www.antares-life.eu
info@antares-life.eu
The PROJECT 3
The LIFE+ Project
ANTARES
The REACH legislation requires that all chemicals present in the European
market in an amount higher than 1 t/year have suitable safety information
EC REGULATION No 1907/2006 - Registration, Evaluation, Authorisation and restriction of CHemicals
REACH states that Non-Testing Methods (NTM)
can be used to fulfill this requirement
Before making an animal experiment the
industry should verify if alternative methods exist.
The ACTIONS
The NTM methods are examples of alternative
methods which predict the effects of chemicals ANTARES is organized in 13 Actions:
without the use of the real compound, but only Action 1
on the basis of the compound structure. Survey of current methods for compliance to
REACH legislation
They include Quantitative Structure-Activity Rela-
tionship (QSAR) models and Read-Across. Action 2
Identification of criteria for non-testing methods
for REACH legislation
However, so far there is a gap of knowledge on
Action 3
which methods are available and can be used Identification of suitable experimental databas-
in practice. es/data sets for ecotoxicological, toxicological
and environmental endpoints
The ANTARES project aims to reduce this gap Action 4
List of (Q)SAR models for ecotoxicological,
assessing NTM as an alternative approach for the toxicological and environmental endpoints for
REACH, and their review
REACH legislation. see Page 8
Action 5
The MAIN OBJECTIVES of ANTARES are: Validation of non-testing methods
Action 6
• to verify the possible USE and Identification of boundaries for best use of
PERFOMANCE of the NTM for REACH; models (applicability domain) and of the assess-
ment factors
• to identify REQUIREMENTS and CONSTRAINTS
Action 7
originating from the REACH legislation; Architecture for integration of different non-test-
ing methods for best performances and cover-
• to identify SAFETY ASSESSMENT FACTORS age of applicability
for the NTM; Action 8 Communication and Dissemination
• to identify the BEST APPLICABILITY Action 9 Web Portal
for a safer use of the NTM; see Pages 6-9
• to INTEGRATE DIFFERENT NTM Action 10 Project Management
achieving superior perfomance; Action 11 Monitoring
• to DISSEMINATE the results; Action 12 Audit
• to PROMOTE NTM for legislative purposes. Action 13 After-LIFE Communication plan
The main result will be a CHARACTERIZATION of http://www.antares-life.eu/actions.php
the NON- TESTING METHODS suitable for REACH
http://www.antares-life.eu/reach-ntm.php
4 REACH and NON-TESTING METHODS
REACH and
NON-TESTING METHODS
Promotion of Non-Testing Methods (NTM)
for their use in the REACH context linking
scientists, regulators and industries
Article 1 of REACH
This Regulation should ensure a high level of
protection of human health and the environment
to EVALUATE as well as the free movement of substances in
and VALIDATE preparations and in articles, while enhancing
competitiveness and innovation.
existing NTM for This Regulation should also promote the
their application development of alternative methods for the assess-
according to ment of hazards of substances.
REACH NEEDS
ANTARES is going on with the evaluation and assessment of the
available NTM, in particular Quantitative Structure-Activity Relationship
(QSAR) models , and the promotion of new tools and resources.
http://www.antares-life.eu/reach-ntm.php
http://echa.europa.eu/legislation/reach_legislation_en.asp
REACH and NON-TESTING METHODS 5
QSAR tools for REACH purposes can be
used for SEVEN REASONS
Innovative tools
Time for experiments
Occurrence of enough laboratories/resources
Æ
Reduction of costs
Use of animals
Prioritization needs
Pro-active approach for greener chemicals
For each of them we can identify the CURRENT CRITICAL ISSUES
and propose SOLUTIONS through ANTARES
1. INNOVATIVE TOOLS 4. REDUCTION OF COSTS
Current methods are not sufficient. Costs for experiments would
Innovation is clearly mentioned within be billions of euros and a huge problem
the REACH legislation. for SMEs. Part of them could be avoided
ANTARES promotes a new platform using cheaper in silico methods.
wrapping several models: ANTARES promotes cheap and /or free
VEGA - Virtual models for property Evaluation solutions.
of chemicals within a Global Architecture
http://www.vega-qsar.eu
5. USE OF ANIMALS
The usage of animals is a strong ethical
2. TIME FOR EXPERIMENTS issue in Europe. REACH requires using
The time requested to produce with millions of animals: part of them could
in vivo methods all the data required by be avoided through in silico methods.
REACH would be very long. Industry faces ANTARES promotes non-animal testing.
long time to get the experimental values.
ANTARES promotes faster tools, e.g. through 6. PRIORITIZATION NEEDS
the VEGA platform. REACH requires prioritizing
chemicals. Today autorithies are
capable to check 5% of chemicals.
3. OCCURRENCE OF ENOUGH In silico methods offer tools to sort them
LABORATORIES/RESOURCES according to their toxicity.
As highlighted in the ANTARES Action 1, ANTARES promotes tools suitable for
in Europe there is a lack of laboratories prioritisation (VEGA), and Italian regulators
capable to perform tests requested by are interested in these tools.
REACH.
http://www.antares-life.eu/action1.php 7. PRO-ACTIVE APPROACH
FOR GREENER CHEMICALS
ANTARES promotes new resources, collaboration So far chemicals have been prepared
and networking. With Italian Authorities for and toxicity has been discovered later.
REACH a NETWORK OF LABORATORIES expert Safer and “greener” products need to be
on QSARs has been identified. designed since the beginning.
http://www.antares-life.eu/reach-ntm.php ANTARES supports tools for safer chemicals,
in contact with selected industries.
6 WEB PORTAL OVERVIEW
ANTARES WEB PORTAL
OVERVIEW
The ANTARES project deals with innovative technologies
and advanced interactive tools.
This implies an active and propositive presence in the
Internet, with an updated and easy-to-use web site.
www.antares-life.eu
The ANTARES Web Portal is aimed to provide
the user with a prompt information about the
project activities and the development itself of
ON GOING Action
the project, just from the Home page through a
visual code which gives an immediate overview
ACCOMPLISHED Action
of the state-of-the-art of the Actions.
NOT STARTED Action
The status and results of each action are regu-
larly updated, with public related documents
uploaded to the website as downloadable
resource and/or as specific website sections.
Latest News about the project’s results, as well
as about in silico approaches related news,
events and resources are frequently published
and highlighted.
http://www.antares-life.eu/index.php
http://www.antares-life.eu/actions.php
http://www.antares-life.eu/results.php
WEB PORTAL SECTIONS 7
The SECTIONS
of the WEB PORTAL
The contents of the ANTARES Web Portal are organized in the
following main sections:
EVENTS
RESOURCES
SOFTWARE
E-LEARNING
EVENTS
http://www.antares-life.eu/events.php
The EVENTS section includes all the events
related to the activities of the ANTARES
project, organized in the following sub-
categories:
• Seminars for the European
regulatory bodies
• International events’ participation
• Didactic courses and initiatives
• Events towards industry
• Workshops and seminars
• Meetings with national
regulatory bodies
• Project meetings
8 WEB PORTAL SECTIONS
The SECTIONS
of the WEB PORTAL
RESOURCES
http://www.antares-life.eu/resources.php
All the public available documents are upload-
ed in the RESOURCES section.
The resources have been organized in three
sub-categories:
• OFFICIAL DOCUMENTS (deliverables,
brochures, newsletters, boards, etc.)
• PRESENTATIONS given by ANTARES
beneficiaries with acknowledgement to
the project
• POSTERS about ANTARES
SOFTWARE
http://www.antares-life.eu/software.php
The SOFTWARE section has been implement-
ed on the basis of the activities within Action
4 (List of (Q)SAR models for the ecotoxicologi-
cal, toxicological and environmental endpoints
for REACH, and their review) and includes a list
of available resources (free and commercial
software as well as articles regarding QSAR
models) possibly usable for mostly all REACH
endpoints.
This page allows the visualizing of the soft-
ware available, as well as the type of software
(both commercial and free or only free soft-
ware) for each endpoint.
http://www.antares-life.eu/action4.php
WEB PORTAL SECTIONS 9
The SECTIONS
of the WEB PORTAL
E-LEARNING
http://www.antares-life.eu/learning.php
The E-LEARNING section provides didactic ma-
terial for understanding QSAR and is suitable QSAR
for beginners and students allowing to down-
load or view on-line presentations, e-book and
other type of learning materials.
Contents are organized in six areas:
In the Updates page you can find the last articles posted on the blog.
In the sidebar there are a lot of useful links organized by categories.
Remember that to post comments you have to be registered to the site.
The Introduction section provides you general information about QSAR.
This section answers questions about what QSARs are, why using QSAR
models and the relationship between QSAR and REACH European legislation.
The Theory page studies deeply mathematical and statistical aspects
about QSAR. Here you can find algorithms and equations
that describe how QSAR models work under the hood.
In theHow to Use section there are useful video-presentation about
pratical use of the software in order to obtain chemical prediction.
In the Online Resources section you can find material like source code,
software and other interesting links. Here practical aspects about QSAR
models are described. Furthermore from here it is possible to
download software and related tutorial to make your own predictions.
F.A.Q. (Frequently Asked Questions)
Finally in the page you can
interact with our staff. Your impressions about the site and the QSAR
in general are very precious for us.
10 BENEFICIARIES
Project BENEFICIARIES
1 Istituto di Ricerche Farmacologiche Mario Negri (Coordinator)
The MARIO NEGRI INSTITUTE FOR PHARMACOLOGICAL RESEARCH (IRFMN) is a not-for-
profit biomedical research organization, founded in Milan in 1961, with research units
also in Bergamo, at Ranica – near Bergamo – and at Santa Maria Imbaro, near Chieti.
The Institute’s main aim is to help defend human health and life.
The Laboratory of Environmental Chemistry and Toxicology at IRFMN is coordinating/coor-
dinated in the past 13 EC projects, and is participating, or has participated, to 17 other EC projects.
These projects deal with QSAR, toxicity, Information Technologies, dissemination of knowledge and re-
sults and integration of knowledge. Within one of these projects, CAESAR, a software platform has been
developed including available QSAR models for REACH. Within the project DEMETRA, a new software for
regulatory purposes for pesticides has been developed.
2 Istituto Superiore di Sanità 3 Federchimica
The ISTITUTO SUPERIORE DI SANITÀ (ISS), es-
tablished in Rome, is the leading technical and
scientific public body of the Italian National
Health Service.
FEDERCHIMICA is the abbreviated
Its activities include research, control, training
name of the ITALIAN FEDERATION OF
and consultation in the interest of public health protection. The
THE CHEMICAL INDUSTRY, founded in
Institute conducts scientific research in a wide variety of fields,
1920. At the present time 1,300 com-
from cutting-edge molecular and genetic research to population-
panies, with a total of 94,000 employ-
based studies of risk factors for disease and disability. Research
ees, are part of Federchimica. They are
priorities are based on those set forth in the National Health Plan.
grouped into 16 Associations, which
in turn are subdivided into 43 product
4 Politecnico di Milano groups. Federchimica is a member of
Confindustria (General Confederation
The POLITECNICO DI MILANO of the Italian Industry) and CEFIC (Eu-
University was established in 1863 ropean Chemical Industry Council). Its
and it is now ranked as one of the primary objectives are the coordina-
most outstanding European univer- tion and the protection of the role of
sities in Engineering, Architecture and Industrial Design. the Italian chemical industry as well
The Department of Electronics and Information of the Politecnico as the promotion of its development
di Milano is a unique environment that blends competences and capacity.
disciplines usually mapped in separate CS and EE departments.
At DEI cross-fertilization is a working reality where researchers are 5 KnowledgeMiner
eager to tackle complex and challenging problems, contributing
to shape key achievements in computer engineering, telecom- The KNOWLEDGEMINER SOFTWARE is
munications, systems and control, electronics. a German privately held company in the
field of research, consulting, develop-
ment, and application of unique self-organising, inductive, knowledge discovery tech-
nologies. The company developed the KnowledgeMiner® software package, a distin-
guished commercial self-organising modelling tool. It implements an innovative set of
high-performance parallel algorithms for modelling and validation of complex systems
to allow knowledge extraction from noisy data in a most objective and automated way.Alternative Non-Testing
methods Assessed for
REACH Substances
www.antares-life.eu
info@antares-life.euThe LIFE Programme
LIFE (L’Instrument Financier pour l’Environnement) is the EU’s funding instrument
for the environment, launched by the European Commission and coordinated by
the Environment Directorate-General.
The general objective of LIFE is to contribute to the implementation, updating and
development of EU environmental policy and legislation by co-financing pilot or
demonstration projects with European added value.
LIFE began in 1992 and to date there have been three complete phases of the programme (LIFE
I: 1992-1995, LIFE II: 1996-1999 and LIFE III: 2000-2006). During this period, LIFE has co-financed
some 3104 projects across the EU, contributing approximately €2.2 billion to the protection of the
environment.
LIFE+ The current phase of the programme, LIFE+, runs from 2007-2013 and has a budg-
et of €2.143 billion. The legal basis for LIFE+ is the Regulation (EC) No 614/2007.
LIFE+ covers both the operational expenditure of DG Environment and the co-financing of
projects. According to Article 6 of the LIFE+ Regulation, at least 78 percent of the LIFE+ budget-
ary resources must be used for project action grants (i.e. LIFE+ projects).
During the period 2007-2013, the European Commission will launch one call for LIFE+ project
proposals per year.
The ANTARES project has been declared eligible under the programme component
LIFE+ Environment Policy and Governance.
The Environment Policy & Governance component continues and extends the former LIFE
Environment programme. It will co-finance innovative or pilot projects that contribute to the
implementation of European environmental policy and the development of innovative policy
ideas, technologies, methods and instruments. It will also help monitor pressures (including the
long-term monitoring of forests and environmental interactions) on our environment.
http://ec.europa.eu/environment/life/about/index.htm
Alternative Non-Testing
methods Assessed for LIFE08
REACH Substances ENV/IT/00435You can also read
